Flex Pharma is on the lookout for a new chief after co-founder Christoph Westphal, M.D., Ph.D., is stepping down from his CEO role.
In the interim, the thinly trade micro-cap has put its R&D head William McVicar, Ph.D., in charge, while ex-GSK staffer Westphal stays on as chair of the board, but also goes back to his VC role full-time as partner at Longwood Fund.
It was in fact Westphal, the serial biotech entrepreneur, who helped the company pull off a $86.4 million IPO (above its expected range) back in 2015 and helped found the company.
Since then it has seen a trial setback, in October last year, when the biotech posted a mixed bag of results for its exploratory nocturnal leg cramps (NLC) study of FLX-787 oral disintegrating tablet. In this crossover study, 72 subjects who suffer from nocturnal leg cramps at least four nights per week were enrolled at three clinical sites.
After an initial 2-week placebo run-in period, subjects were randomized to either 17mg ODT FLX-787 or ODT placebo for three weeks. Patients were then crossed over to the other treatment for an additional three weeks.
The biotech said that its preliminary analysis of the entire crossover data set “did not demonstrate a statistically significant difference versus placebo” when it came to its prespecified endpoints of muscle cramp frequency, or cramp-free nights.
It said at the time that it believed that there were some issues at a trial site that messed with these data, but didn’t go into details. This was not enough to appease investors however, as its shares dropped in the mid-teens on the news.
The company is also working on FLX-787 in reducing cramps and spasticity in Charcot-Marie-Tooth (CMT), as well as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).
The med is a small molecule co-activator of the TRPA1 and TRPV1 ion channels, and is believed to help suppress muscle cramps and reduce cramping frequency, as well as the associated pain in those with nocturnal leg cramps.
“I am proud of the progress Flex Pharma has made to date, with the advancements made in the clinical development of FLX-787 for ALS, MS and CMT,” said Westphal.
“Now that Flex is about to initiate two phase 2 studies in the U.S., this is the right time for me to hand the reins to Bill given his extensive clinical development experience and successful track record of multiple drug approvals. As the largest shareholder of Flex, I am confident that Bill and the Flex management team will continue to advance and deliver this important medicine to patients. I look forward to working with the team as chair, and to returning to my full-time venture capital role as Partner at Longwood Fund.”
Westphal has also been CEO of Verastem, until he handed the reins over to president Robert Forrester. He is perhaps best known for launching Sirtris, which GlaxoSmithKline bought out for a whopping $720 million. The pharma giant then shut down the unit in 2013 after making little headway in the clinic, after generating a raucous controversy over the science involved. GSK then absorbed the R&D work into a larger research unit in Pennsylvania.
The well-connected Westphal went on to run GSK's SR One venture group for a short stint and started up the Longwood Fund, later helping found and run Flex Pharma in 2014 with a $40 million financing round.
Shares in the biotech dropped 3.65% on the CEO’s departure last night.